Single Versus Multiple Injections for Axillary Plexus Block

Upper Extremity Clinical Trial

Official title:

Single Versus Multiple Injections for Axillary Plexus Block: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378323
• Other study ID #: BAX Unique
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: April 2019
• Source: Hôpital du Valais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be randomized to one of two groups:

1. Multiple injection group: Axillary brachial plexus block with multiple injections, with the arm abducted, performed with the aid of ultrasound;

2. Single injection group: Axillary brachial plexus block with a single injection, with the arm placed behind the head and the elbow flexed, performed with the aid of ultrasound

Description:

The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups The first group - multiple injection group - will receive an ultrasound-guided axillary brachial plexus block with the traditional technique, i.e. multiple injections of local anesthetic in proximity to the 4 nerfs that innervate the arm. The arm will be abducted during the block procedure.

The second group - single injection group - will receive an ultrasound-guided axillary brachial plexus block with the arm placed behind the head and the elbow flexed. In this position the different nerfs group around the axillary artery where they will be blocked with a single injection of local anesthetic.

All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.

The primary outcome measure is the time needed for the performance of the block. Secondary outcomes are: success rate of the block at 30 minutes after the injection, needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction. These outcomes are further defined in the section below.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 10, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who undergo forearm or hand surgery under axillary brachial plexus block

Exclusion Criteria:

• History of allergic reaction to local anaesthetics

• Peripheral neuropathy

• Renal or hepatic insufficiency

• Coagulation disorders

Related Conditions & MeSH terms

• Upper Extremity

Intervention

Drug:
• Multiple injection local anesthetic
Multiple injection local anesthetic
• Single injection local anesthetic
Single injection local anesthetic

Locations

Country	Name	City	State
Switzerland	Hopital du Valais	Sion

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital du Valais	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance time	Time in minutes from ultrasound probe placement to end of local anesthetic injection	10 minutes
Secondary	Needling time	Time in seconds to complete the block	15 minutes
Secondary	Time to first analgesic request	Time in minutes to first analgesic request postoperatively	24 hours
Secondary	Block-related complications	Infection, bleeding, neurological problems, pain during the 24 postoperative hours	24 hours
Secondary	Postoperative opioid consumption on postoperative day 1	intravenous morphine equivalent consumption during the 24 postoperative hours	24 hours
Secondary	Pain scores at 12 hours postoperatively	Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)	12 hours
Secondary	Pain scores on postoperative day 1	Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)	24 hours
Secondary	Patient satisfaction	Assessed by numerical rating scale on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)	24 hours